Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    11086983 [PUBMED-IDS]
Previous Study | Return to List | Next Study

Treatment Study for Cognitive Deficits in Schizophrenia (TURNS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00505076
Recruitment Status : Completed
First Posted : July 20, 2007
Results First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Collaborators:
University of Maryland, College Park
Washington University School of Medicine
Massachusetts General Hospital
Nathan Kline Institute for Psychiatric Research
Columbia University
Duke University
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Stephen R. Marder, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: MK-0777
Drug: placebo
Enrollment 63
Recruitment Details Patients were recruited between June 2007 and July 2009.
Pre-assignment Details 46 subjects were excluded during screening.
Arm/Group Title MK-0777 8 mg BID MK-0777 3 mg BID Placebo BID
Hide Arm/Group Description Subjects treated with MK-0777 GEM, 8 mg BID(twice daily) Subjects treated with MK-0777 GEM, 3 mg BID (twice daily) Subjects treated with 2 tablets placebo BID (twice daily)
Period Title: Overall Study
Started 22 19 22
Completed 19 17 17
Not Completed 3 2 5
Reason Not Completed
Adverse Event             1             0             1
Protocol Violation             2             1             2
Withdrawal by Subject             0             1             2
Arm/Group Title MK-077 8 mg BID MK-0777 3 mg BID Placebo BID Total
Hide Arm/Group Description Subjects treated with MK-0777 GEM, 8 mg BID(twice daily) Subjects treated with MK-0777 GEM, 3 mg BID (twice daily) Subjects treated with 2 tablets placebo BID (twice daily) Total of all reporting groups
Overall Number of Baseline Participants 22 19 22 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 22 participants 63 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
19
 100.0%
22
 100.0%
63
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 19 participants 22 participants 63 participants
44.9  (8.7) 43.3  (9.3) 40.0  (10.9) 42.7  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 22 participants 63 participants
Female
9
  40.9%
8
  42.1%
6
  27.3%
23
  36.5%
Male
13
  59.1%
11
  57.9%
16
  72.7%
40
  63.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 19 participants 22 participants 63 participants
22 19 22 63
1.Primary Outcome
Title Composite MATRICS Consensus Cognitive Battery Score
Hide Description The primary outcome measure is the composite score on the Matrics Consensus Cognitive Battery (MCCB). The MCCB composite score is a standardized mean of the seven domain scores. T-scores are standardized to normative data, and have an estimated mean of 50 and SD of 10 in the general healthy population. Data reduction for analysis of neurocognitive testing used the following steps: i) individual neurocognitive test scores at baseline and follow-up were converted to t-scores; ii) t-scores within the pre-specified cognitive domains measured by more than one test were averaged to obtain a domain-specific t-score; and iii) domain-specific t-scores were averaged to create the MCCB composite score.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.
Arm/Group Title MK-077 8 mg BID MK-0777 3 mg BID Placebo BID
Hide Arm/Group Description:
Subjects treated with MK-0777, 8 mg BID
Subjects treated with MK-0777 , 3 mg BID
Subjects treated with placebo tablet BID
Overall Number of Participants Analyzed 18 18 17
Mean (Standard Deviation)
Unit of Measure: composite score
27.9  (12.7) 31.3  (13.9) 32.5  (14.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-077 8 mg BID, MK-0777 3 mg BID, Placebo BID
Comments An analysis of covariance (ANCOVA), adjusting for baseline scores, was used to compare treatment groups on cognitive and functional measures. The predefined primary cognition outcome measure was the MCCB (MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia Research) Consensus Cognitive Battery) composite T-score, tested at overall two-sided alpha=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title UPSA(UCSD Performance-Based Skills Assessment) Summary Score
Hide Description The UCSD Performance-Based Skills Assessment assessed functional capacity. The UPSA Summary Score has a range from 0 to 120. A higher score indicates less impairment.
Time Frame Baseline and end of treatment, a total of four weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.
Arm/Group Title MK-077 8 mg BID MK-0777 3 mg BID Placebo BID
Hide Arm/Group Description:
Subjects treated with MK-0777, 8 mg BID
Subjects treated with MK-0777 , 3 mg BID
Subjects treated with placebo tablet BID
Overall Number of Participants Analyzed 18 18 17
Mean (Standard Deviation)
Unit of Measure: UPSA Summary Score
Baseline 91.7  (13.4) 85.0  (18.8) 95.0  (16.3)
End of Treatment 90.4  (12.8) 86.3  (18.7) 96.5  (15.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-077 8 mg BID, MK-0777 3 mg BID, Placebo BID
Comments The sample size was determined using the analysis of covariance power formula, n=2[za+zβ]2s2 (1−R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Schizophrenia Cognition Rating Scale (SCoRS) Score
Hide Description The Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity. The SCoRS Interviewer Global Rating of function has a range 1 to 10. Higher ratings indicate greater impairment.
Time Frame 4 Weeks (Baseline to End of Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.
Arm/Group Title MK-077 8 mg BID MK-0777 3 mg BID Placebo BID
Hide Arm/Group Description:
Subjects treated with MK-0777, 8 mg BID
Subjects treated with MK-0777 , 3 mg BID
Subjects treated with placebo tablet BID
Overall Number of Participants Analyzed 18 18 17
Mean (Standard Deviation)
Unit of Measure: SCoRS Score
Baseline 4.1  (2.3) 4.8  (2.3) 3.8  (2.3)
End of Treatment 4.0  (2.4) 4.6  (2.1) 3.6  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-077 8 mg BID, MK-0777 3 mg BID, Placebo BID
Comments The sample size was determined using the analysis of covariance power formula, n=2[za+zβ]2s2 (1−R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MK-077 8 mg BID MK-0777 3 mg BID Placebo BID
Hide Arm/Group Description Subjects treated with MK-0777 GEM, 8 mg BID(twice daily) Subjects treated with MK-0777 GEM, 3 mg BID (twice daily) Subjects treated with 2 tablets placebo BID (twice daily)
All-Cause Mortality
MK-077 8 mg BID MK-0777 3 mg BID Placebo BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MK-077 8 mg BID MK-0777 3 mg BID Placebo BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/21 (4.76%)      1/18 (5.56%)      0/21 (0.00%)    
Infections and infestations       
Medical Hospitalization * [1]  0/21 (0.00%)  0 1/18 (5.56%)  1 0/21 (0.00%)  0
Nervous system disorders       
Psychosis Hospitalization * [2]  1/21 (4.76%)  1 0/18 (0.00%)  0 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Fever with influenza
[2]
Hospitalization for psychosis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
MK-077 8 mg BID MK-0777 3 mg BID Placebo BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/21 (33.33%)      2/18 (11.11%)      5/21 (23.81%)    
General disorders       
Sedation *  2/21 (9.52%)  2 1/18 (5.56%)  1 1/21 (4.76%)  1
Dizziness *  2/21 (9.52%)  2 0/18 (0.00%)  0 1/21 (4.76%)  1
Fever *  2/21 (9.52%)  2 0/18 (0.00%)  0 0/21 (0.00%)  0
Headache *  1/21 (4.76%)  1 0/18 (0.00%)  0 2/21 (9.52%)  2
Musculoskeletal and connective tissue disorders       
Limb pain *  0/21 (0.00%)  0 1/18 (5.56%)  1 1/21 (4.76%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephen R. Marder
Organization: Semel Institute at UCLA
Phone: 310-268-3647
EMail: marder@ucla.edu
Publications:
Layout table for additonal information
Responsible Party: Stephen R. Marder, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00505076     History of Changes
Other Study ID Numbers: TURNS02
HHSN278200441003C ( Other Grant/Funding Number: NIMH grant )
First Submitted: July 19, 2007
First Posted: July 20, 2007
Results First Submitted: April 27, 2011
Results First Posted: October 31, 2014
Last Update Posted: October 31, 2014